Trial · NCT02695719
Lubiprostone for Treatment of Chronic Idiopathic Constipation
NCT02695719, Phase 3, Completed, Takeda; results first posted 2018-12-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lubiprostone for Treatment of Chronic Idiopathic Constipation. Trials, record NCT02695719. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02695719
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lubiprostone for Treatment of Chronic Idiopathic Constipation
- NCT number
- NCT02695719
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 156 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Chronic Idiopathic Constipation
- Interventions
- Placebo, Lubiprostone
- First posted
- 2016-03-01
- Last updated
- 2018-12-31
- Results first posted
- 2018-12-31
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Spontaneous Bowel Movement (SBM) Frequency at Week 1 | Week 1 | A SBM was defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it. |
| Secondary | SBM Frequency at Weeks 2, 3 and 4 | Weeks 2, 3 and 4 | A SBM was defined as any BM that does not occur within 24 hours after rescue medication use. Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it. |
| Secondary | Percentage of Participants Who Had a SBM Within 24 Hours After the First Dose of Study Medication | Up to 24 hours after the first dose of study medication | A SBM was defined as any BM that does not occur within 24 hours after rescue medication use. Percentage of participants who have an SBM within 24 hours after the first dose will be assessed and derived from the data on SBMs collected in the participant diary. |
| Secondary | Mean Degree of Straining Score | Weeks 1, 2, 3 and 4 | For each participant, the mean degree of straining was averaged for all SBMs in a given week. The degree of straining for each SBM was collected in the participant diary. The degree of straining is scored on a 5-point scale where: 0=No straining, 1=Mild straining, 2=Moderate straining, 3=Strong straining or 4=Very strong straining with higher scores indicating more severe straining. |
| Secondary | Mean Degree Stool Consistency Score | Weeks 1, 2, 3 and 4 | For each participant, the mean stool consistency score was averaged for all SBMs in a given week. The mean degree of stool consistency for each SBM was collected in the participant diary based on the Bristol Stool Chart. The Bristol Stool Chart is a visual medical aid designed to classify the form of human feces into seven categories where: 1=Hard and round (difficult-to-pass), 2=Sausage-shaped but hard stool, 3=Sausage-shaped stool with cracks on the surface, 4=Sausage-shaped, soft stool with smooth surface, or coiled stool, 5=Soft, half-solid (and easy-to-pass) stool with clear crease, 6=Unshaped, loose stool with small, irregular-shaped pieces, or mushy stool or 7=Watery stool without solid pieces (entirely liquid). |
| Secondary | Weekly Abdominal Symptoms Score | Weeks 1, 2, 3 and 4 | The abdominal symptoms (bloating and discomfort upon waking in the morning) were scored weekly on a 5-point scale, where: 0=None, 1=Mild, 2=Moderate, 3=Severe or 4=Very severe, with a higher score indicating more severe symptoms. Assessment of weekly abdominal symptoms were recorded by the participant in the diary. |
| Secondary | Weekly Responder Rate | Weeks 1, 2, 3 and 4 | The responder rate was assessed each week and was derived from the data on SBMs collected in the diary. A non-responder was defined as any participant with a spontaneous BM frequency rate of less than 3 for a given week, any participant who dropped out during or before the given week due to lack of efficacy, or any participant who used rescue medication during or within 24 hours before the given week. Otherwise, the participant subject was considered a responder. A responder with a spontaneous BM frequency rate ≥3 but \<4 was considered a moderate responder. Otherwise, the participant was a full responder (≥4 SBM). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Spontaneous Bowel Movement (SBM) Frequency at Week 1 | Week 1 | FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by last observation carried forward (LOCF) method. | SBMs/week | MEAN |
| SECONDARY | SBM Frequency at Weeks 2, 3 and 4 | Weeks 2, 3 and 4 | FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method. | SBMs/week | MEAN |
| SECONDARY | Percentage of Participants Who Had a SBM Within 24 Hours After the First Dose of Study Medication | Up to 24 hours after the first dose of study medication | FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Here, number of participants analyzed is the participants who were evaluated for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Mean Degree of Straining Score | Weeks 1, 2, 3 and 4 | FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method. | scores on a scale | MEAN |
| SECONDARY | Mean Degree Stool Consistency Score | Weeks 1, 2, 3 and 4 | FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method. | scores on a scale | MEAN |
| SECONDARY | Weekly Abdominal Symptoms Score | Weeks 1, 2, 3 and 4 | FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method. | scores on a sclae | MEAN |
| SECONDARY | Weekly Responder Rate | Weeks 1, 2, 3 and 4 | FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Spontaneous Bowel Movement (SBM) Frequency at Week 1 | Placebo | 3.1 | Standard Deviation 1.75 | SBMs/week | |
| Spontaneous Bowel Movement (SBM) Frequency at Week 1 | Lubiprostone 24 μg | 4.4 | Standard Deviation 2.65 | SBMs/week | |
| SBM Frequency at Weeks 2, 3 and 4 | Placebo | Week 2 | 3.2 | Standard Deviation 1.80 | SBMs/week |
| SBM Frequency at Weeks 2, 3 and 4 | Lubiprostone 24 μg | Week 2 | 4.2 | Standard Deviation 2.39 | SBMs/week |
| SBM Frequency at Weeks 2, 3 and 4 | Placebo | Week 3 | 3.4 | Standard Deviation 1.98 | SBMs/week |
| SBM Frequency at Weeks 2, 3 and 4 | Lubiprostone 24 μg | Week 3 | 4.1 | Standard Deviation 2.42 | SBMs/week |
| SBM Frequency at Weeks 2, 3 and 4 | Placebo | Week 4 | 3.2 | Standard Deviation 1.75 | SBMs/week |
| SBM Frequency at Weeks 2, 3 and 4 | Lubiprostone 24 μg | Week 4 | 4.0 | Standard Deviation 2.31 | SBMs/week |
| Percentage of Participants Who Had a SBM Within 24 Hours After the First Dose of Study Medication | Placebo | 35.1 | percentage of participants | ||
| Percentage of Participants Who Had a SBM Within 24 Hours After the First Dose of Study Medication | Lubiprostone 24 μg | 56.8 | percentage of participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 74 | |
| Overall Study | STARTED | Lubiprostone 24 μg | 82 | |
| Overall Study | COMPLETED | Placebo | 71 | |
| Overall Study | COMPLETED | Lubiprostone 24 μg | 72 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Lubiprostone 24 μg | 10 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 74 | |
| other | Nausea | Gastrointestinal disorders | Lubiprostone 24 μg | 19 | 81 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 5 | 74 | |
| other | Dyspepsia | Gastrointestinal disorders | Lubiprostone 24 μg | 6 | 81 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 74 | |
| other | Diarrhoea | Gastrointestinal disorders | Lubiprostone 24 μg | 5 | 81 | |
| other | Headache | Nervous system disorders | Placebo | 0 | 74 | |
| other | Headache | Nervous system disorders | Lubiprostone 24 μg | 5 | 81 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 74 |
| Total, all-cause mortality | Lubiprostone 24 μg | 0 | 81 |
| Total, other adverse events | Placebo | 8 | 74 |
| Total, other adverse events | Lubiprostone 24 μg | 28 | 81 |
| Total, serious adverse events | Placebo | 0 | 74 |
| Total, serious adverse events | Lubiprostone 24 μg | 0 | 81 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lubiprostone 24 μg vs Placebo: deaths from any cause | Trial comparisons |
| Lubiprostone 24 μg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02695719
GET https://conductscience.org/api/trials/v1/NCT02695719/results?page=2